Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT02502500
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/sq.meters, inclusive.
* Subjects with the following genotype based upon pharmacogenetic testing results: CYP2C9 EM: \*1\*1.
Exclusion Criteria:
* Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
* Positive serology results for HBsAg, HCV, and HIV at Screening.
* Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of \<65 mL/minute/1.73 sq.meters.
* Known hypersensitivity to celecoxib or sulfonamides.
* History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
* Known active cancer or history of chemotherapy use within the previous 24 months.
* Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
* Current or past history of gastrointestinal bleeding.
* Any history of alcohol or drug abuse within the previous year prior to Screening.
* Subjects with a known history of smoking and/or have used nicotine or nicotine containing products within the past 6 months.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02502500
Study Brief:
Protocol Section:
NCT02502500